Overview
- 8 FDA inspections are on record.
- 5 inspections produced a Form 483.
- The most recent recorded inspection date is 2024-10-25.
At a glance
Inspections
8
Form 483s
5
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 18 Oct 2024 – 25 Oct 2024 | Medical Devices & Rad Health | 483 | View 483 → |
| 7 Dec 2021 – 16 Dec 2021 | Medical Devices & Rad Health | 483 | View 483 → |
| 3 Oct 2016 – 25 Oct 2016 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Dec 2012 | Not recorded | 483 | View 483 → |
| 27 Apr 2009 | Not recorded | 483 | View 483 → |
| 30 Dec 2003 | Not recorded | Clean | |
| 23 Aug 2002 | Not recorded | Clean | |
| 19 Apr 2001 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
16 Dec 2021
21 CFR 820.198(a)
Lack of or inadequate complaint procedures
Cited by Benjamin J Dastoli, Brian M Marosan
16 Dec 2021
21 CFR 820.30(i)
Design changes - Lack of or Inadequate Procedures
Cited by Benjamin J Dastoli, Brian M Marosan
16 Dec 2021
21 CFR 820.40
Procedures not adequately established or maintained
Cited by Benjamin J Dastoli, Brian M Marosan
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.75(a) | Cited across public-safe Form 483 observations | 5x |
| 21 CFR 820.50(a) | Cited across public-safe Form 483 observations | 3x |
| 21 CFR 803.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 806.10(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.50(a)(2) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.198(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.40 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.50 | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.72(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Pemco Inc's 5 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat